11.07.2015 Views

Liquid Handling

Liquid Handling

Liquid Handling

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Quality ManagementTechnical InformationQuality ManagementQuality management is briefly described for liquid handlinginstruments and BLAUBRAND ® volumetric instrumentsQuality management at BRANDbegins at product conceptionand continues through the designprocess and production.Routine checks throughout theentire manufacturing processresult in volumetric instrumentswith the smallest possible deviationfrom the true volume(accuracy) and narrow scatterof individual values (coefficientof variation). The final step ofthis Statistical Process Controlis random finished productsampling according to DINISO 3951.The quality management systemapplied at BRAND andcertified to DIN EN ISO 9001 isa combination of process monitoringand random checks. Theaccepted quality level (AQL) isless than or equal to 0.4., i.e.,the limiting values are met witha statistical certainty of at least99.6 %.All measuring instruments usedin quality control are regularlychecked and are referenced tothe national standards of PTB(The German Federal Instituteof Physics and Metrology).Quality management accordingto DIN EN ISO 9001 is thebasis for issuing of calibrationcertificates (e.g., our certificatesof performance).All test results are documentedand filed for 7 years. Ifthe batch or serial number isknown, each specific test resulton the date of production canbe traced.As BRAND manufacturesconformity certified volumetricinstruments, the quality ofproducts is automatically supervisedby the "Eichamt",the German State Office ofWeights and Measures. Therequirements for monitoring ofmeasuring instruments, traceabilityto national standards,and staff qualification are fullymet.Conformity CertificationFor volumetric instruments which are kept and used for commercialpurposes (e.g., medical and pharmaceutical purposes) the German"Eichordnung" dated 12 August 1988 calls for conformitycertification instead of official calibration. This also applies forvolumetrically relevant accessories (e.g., pipette tips for pistonoperatedpipettes).Conformity means: compliance of an instrument with the "Eichordnung",the German Federal Weights and Measures Regulations,Annex 12. The conformity certification procedure is described inDIN 12 600.The conformity symbol "H" and the manufacturer code designation(for BRAND it is "B") or, on request the "Eichamt" (the GermanState Office of Weights and Measures, with a separate conformitysymbol) certifies the product as complying with the "Eichordnung"for Official Certification and corresponding standards. In generalthe product itself carries the symbol of conformity or, with disposables,the packaging.Note!The conformity certification applies onlyto volumetric instruments. Therefore,thermometers and density bottles continueto be officially certified.318info@brand.de

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